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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia

This is a nonrandomized study of ruxolitinib in combination with a standard multi-agent chemotherapy regimen for the treatment of B-cell acute lymphoblastic leukemia. Part 1 of the study will optimize the dose of study drug (ruxolitinib) in combination with the chemotherapy regimen. Part 2 will evaluate the efficacy of combination chemotherapy and ruxolitinib at the recommended dose determined in Part 1.
Pediatric Leukemia
Phase II
Children
Chemotherapy - cytotoxic, Mol. targeted/Immunotherapy/Biologics, Supportive Care
6-thioguanine (6-TG), Cyclophosphamide (CPM), Cytarabine (ARA-C), Dexamethasone, Doxorubicin, Leucovorin, Mercaptopurine, Methotrexate, Pegaspargase (PEG-ASP), Ruxolitinib, Vincristine
Friedman, Debra
National
Vanderbilt University
04-30-2018
Treatment
VICCPED16131
NCT02723994

Eligibility

1 Years
BOTH
NO
Inclusion Criteria:

Eligible for study when participant is 1 year to 21 years at the time of diagnosis

Eligible Ages in Australia and Canada; 2 years to 21 years

De novo high-risk (HR) Ph-like B-ALL for which any of following criteria are present at diagnosis:

Age ? 10 years

White blood cell (WBC) ? 50 × 10^3/?L

CNS3 leukemia

Systemic steroid pretreatment without presteroid WBC documentation

One of the following Ph-like ALL genetic lesions must be present in the diagnostic bone marrow or peripheral blood sample:

CRLF2 rearrangement with JAK1 or JAK2 mutation (JAK+)

CRLF2 rearrangement without JAK mutation

Other JAK pathway alterations (eg, JAK2 fusions, erythropoietin receptor (EPO-R) fusions, SH2B3 deletions, interleukin-7 receptor-alpha (IL7RA) mutations) with or without CRLF2 rearrangement

Completed a 4-drug Induction therapy regimen (modified aBFM regimen or equivalent) in Study AALL1131 or as the institutional standard of care for HR B-ALL and have had end-Induction minimal residual disease (MRD) assessed

Male and female subjects of reproductive non childbearing potential or willing to take appropriate precautions to avoid pregnancy or fathering a child for the duration of study participation



Exclusion Criteria:

Receipt of any other cytotoxic chemotherapy before Induction therapy, with exception of hydroxyurea or steroid pretreatment

Trisomy 21 (Down syndrome)

BCR-ABL1-rearranged (Ph+) ALL

Calculated creatinine clearance or radioisotope glomerular filtration rate
Alanine aminotransferase ? 5 × upper limit of normal (ULN) for age

Direct bilirubin ? 1.5 × ULN (may be assumed if total bilirubin is below ULN)

History or evidence of cirrhosis

Platelet count
Absolute neutrophil count (ANC)
Positive screen for hepatitis B or C

Known human immunodeficiency virus infection

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